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High RiskFDA
Hologic, Inc
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for...
Medical Devices·535 affected·Aug 2, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archiv...
Medical Devices·101 affected·Aug 2, 2016
High RiskFDA
Hologic, Inc
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for...
Medical Devices·1,440 affected·Aug 2, 2016
High RiskFDA
Randox Laboratories Ltd.
Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in...
Medical Devices·18 affected·Aug 2, 2016
High RiskFDA
Best Sanitizers Inc
Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set ...
Medical Devices·3,023 affected·Aug 2, 2016
RecallFDA
Alere San Diego, Inc.
LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the...
Medical Devices·12,951 affected·Aug 2, 2016
CriticalFDA
Bayer Healthcare
Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The M...
Diagnostic Devices·165 affected·Aug 2, 2016
CriticalFDA
Life Rising Corp S
The product is packaged in a white plastic bottle with green lettering. The label reads in part "LIFE RISING DHZC-2, blood circulation re...
Supplements·216 affected·Aug 1, 2016
High RiskFDA
Odyssey Enterprises Inc
Split Cooked King Crab Leg & Claw, repacked by Odyssey, net wt. 20 lbs. per box, keep frozen. UPC 28575 96323 The label is read in p...
Seafood·400 affected·Aug 1, 2016
High RiskFDA
Isomeric Pharmacy Solution, Llc
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isom...
Injectable Drugs·2,331 affected·Aug 1, 2016
High RiskFDA
Spectrum Laboratory Products, Inc.
Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901
Drugs·14,000 affected·Aug 1, 2016
CriticalFDA
Town And Country Compounding And Consultation Services
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ...
Injectable Drugs·12 affected·Aug 1, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, an...
Medical Devices·37 affected·Aug 1, 2016
High RiskFDA
Aesculap Implant Systems Llc
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Medical Devices·180 affected·Aug 1, 2016
High RiskFDA
Ethicon, Inc.
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Medical Devices·396,024 affected·Aug 1, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembl...
Medical Implants·2,039 affected·Aug 1, 2016
RecallUSDA
Michael Angelo's Gourmet Foods Inc.
Michael Angelo's Gourmet Foods, Inc. Recalls Shrimp Scampi and Meat Lasagna Products Due To Misbranding and Undeclared Allergens
Poultry·0 affected·Aug 1, 2016
RecallUSDA
Michael Angelo's Gourmet Foods Inc.
Michael Angelo's Gourmet Foods, Inc. Retira Productos De Camarn Scampi Por Error De Rotulacin Y Alrgenos No Declarados
Meat & Poultry·0 affected·Aug 1, 2016
CriticalFDA
Minnie Marie Bakers, Inc. Dba Awrey's Bakery
Devils Food Sheet Cake 8x12 Mega 28.125 lb case 20, 2 2.5oz cakes per case
Bakery & Grains·2,418 affected·Jul 29, 2016
CriticalFDA
Sm Fish Corp.
OSSIE'S PICKLED LOX & CREAM, NET WT. 8 OZ., UPC 739885104113; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Dairy·336 affected·Jul 29, 2016
CriticalFDA
Hampton Creek Foods
JUST Devil's Food Cake Mix; NET WT 20 oz. (1 lb 4 oz) 567 g); UPC 8 54829 00643 5. Ingredients: Muffin Mix: Enriched flours, {ble...
Dairy·3,786 affected·Jul 29, 2016
CriticalFDA
Hampton Creek Foods
JUST White Cake Mix; NET WT 20 oz. (1 lb 4 oz) 567 g); UPC 8 54829 00688 6. Ingredients: Enriched flours, {bleached (wheat flour, ni...
Dairy·2,421 affected·Jul 29, 2016
CriticalFDA
Sm Fish Corp.
OSSIE'S STIGLITZ HERRING, NET WT. 7 OZ., UPC 739885109064; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Food·336 affected·Jul 29, 2016
CriticalFDA
Sm Fish Corp.
OSSIE'S PICKLED LOX, NET WT. 8 OZ., UPC 739885104137; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Food·336 affected·Jul 29, 2016
CriticalFDA
Sm Fish Corp.
OSSIE'S HONEY MUSTARD HERRING; NET WT. 7 OZ. 739885109019; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Food·336 affected·Jul 29, 2016
CriticalFDA
Sm Fish Corp.
OSSIE'S SWEDISH MATJES HERRING, NET WT. 7 OZ., UPC 739885109101; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Food·336 affected·Jul 29, 2016
CriticalFDA
Hampton Creek Foods
JUST Cinnamon Roll Coffee Cake Mix; NET WT 26.9 oz. (1 lb 10.9 oz) 762 g); UPC 8 54829 00644 2. Ingredients: Cake Mix: Enriched flou...
Dairy·3,731 affected·Jul 29, 2016
CriticalFDA
Minnie Marie Bakers, Inc. Dba Awrey's Bakery
White Sponge Cake 8x12 30 lb case 20, 24oz cakes per case
Bakery & Grains·1,106 affected·Jul 29, 2016
CriticalFDA
Ask Foods Inc
Taste of Inspirations Classic Red Skin Potato Salad; Creamy redskin potatoes & white onion in a tangy dressing. Net Wt. 16 OZ. Sell By: 0...
Produce·0 affected·Jul 29, 2016
High RiskFDA
Drews Llc
SimplyNature Organic Chipotle Ranch Dressing, Net Wt. 12 FL OZ (354mL), UPC: 0 41498 21862 1
Snacks & Candy·2,011 affected·Jul 29, 2016
CriticalFDA
Sm Fish Corp.
OSSIE'S PICKLED HERRING, NET WT. 8 OZ., UPC 739885104175; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Food·336 affected·Jul 29, 2016
CriticalFDA
Sm Fish Corp.
OSSIE'S ROMAN SHMALTZ HERRING, NET WT. 7 OZ., UPC 739885109026; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Food·336 affected·Jul 29, 2016
CriticalFDA
Sm Fish Corp.
OSSIE'S PICKLED HERRING CLEAR, NET WT. 8 OZ., UPC 739885104205; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Food·336 affected·Jul 29, 2016
CriticalFDA
Minnie Marie Bakers, Inc. Dba Awrey's Bakery
Chocolate Roll Cake 15x24 22 lb case 8, 2 lb 12 oz cakes per case
Bakery & Grains·2,971 affected·Jul 29, 2016
CriticalFDA
Minnie Marie Bakers, Inc. Dba Awrey's Bakery
Deep Chocolate Sheet Cake 8x12 28.125 lb case 20, 22.5 oz cakes per case
Bakery & Grains·560 affected·Jul 29, 2016
CriticalFDA
Sm Fish Corp.
OSSIE'S TAAM SHABBOS HERRING, NET WT. 7 OZ., UPC 739885109057; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Food·336 affected·Jul 29, 2016
CriticalFDA
Sm Fish Corp.
OSSIE'S WASABI HERRING, NET WT. 7 OZ., UPC 739885109088; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Food·336 affected·Jul 29, 2016
CriticalFDA
Hampton Creek Foods
JUST Chocolate Chunk Muffin Mix; NET WT 20.8 oz. (1 lb 4.8 oz) 590 g); UPC 8 54829 00656 5. Ingredients: Muffin Mix: Enriched flours...
Dairy·1,569 affected·Jul 29, 2016
CriticalFDA
Hampton Creek Foods
JUST Yellow Cake Mix; NET WT 20 z. (1 lb 4oz) 567 g); UPC 8 54829 00642 8. Ingredients: Enriched flours, {bleached (wheat flour, nia...
Dairy·3,938 affected·Jul 29, 2016
High RiskFDA
Sage Products Llc
2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #97...
Drugs·2,756 affected·Jul 29, 2016
High RiskFDA
Teva Pharmaceuticals Usa
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wale...
Injectable Drugs·27,547 affected·Jul 29, 2016
CriticalFDA
Sage Products Llc
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into ...
Topical Drugs·576,802 affected·Jul 29, 2016
High RiskFDA
Sage Products Llc
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into ...
Topical Drugs·616,561 affected·Jul 29, 2016
High RiskFDA
Teva Pharmaceuticals Usa
Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales,...
Injectable Drugs·11,844 affected·Jul 29, 2016
High RiskFDA
Zimmer Biomet, Inc.
ROSA BRAIN 3.0.0
Medical Devices·2 affected·Jul 29, 2016
High RiskFDA
B. Braun Medical, Inc.
Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
Medical Devices·15,950 affected·Jul 29, 2016
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Produ...
Surgical Devices·114,081 affected·Jul 29, 2016
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product ...
Surgical Devices·47,989 affected·Jul 29, 2016